MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number	AIA-2000ST
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported "4273 hybrid cup transfer z-axis home overrun" error on the aia-2000 analyzer.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for beta human chorionic gonadotropin (bhcg).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed the issue by observing the error upon powering up.The fse checked the cup picking assembly, which would not consistently return to the home position during an all-set-home.The fse replaced the cup picking assembly for the hybrid arm and verified the resolution by running the cup test exerciser macro without errors.No further action required by field service.The aia-2000 analyzer is operating as expected.A 13 month complaint history review and service history review for similar complaints was performed for "4273 hybrid cup transfer z-axis home overrun" error across all aia-2000 analyzers from february 17, 2025 through aware date of march 17, 2026.There were eleven (11) similar complaints identified during the searched period, including this case.Capa escalation: error 4273 hybrid cup transfer z-axis home overrun is generated when the home sensor activates improperly after movement of hybrid cup transfer z axis.A 13 month retrospective review revealed eleven (11) occurrences of complaints related to "4273 hybrid cup transfer z-axis home overrun" on eight (8) aia-2000 analyzers.Data assessment indicated the reported events were due to various failures that include wear and tear, operational problem, misalignment, fatigue problem, maintenance problem and mechanical failure.The results were improved by performing alignments, maintenance, lubricating assemblies, replacing worn and failed parts and resetting analyzer.There is no indication of a systemic issue and there is no impact to patient safety.The aia-2000 operators manual under appendix 4: error messages states the following: [4273] hybrid cup transfer z-axis home overrun.Cause: the home sensor activated improperly after movement of the hybrid cup transfer z-axis.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to a wear problem of the cup picking assembly, cause traced to component failure.

• Brand Name: AIA-2000
• Common Device Name: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 24854031
• Report Number: 3004529019-2026-00044
• Device Sequence Number: 10549149
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K971103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIA-2000ST
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown